Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Immunomic Therapeutics, Inc. (ITI) is seeking an innovative and highly motivated Sr. Regulatory Affairs professional. As a member of our team, you will be directly involved in creating successful regulatory submissions which will assist in achieving our mission of pioneering vaccines that transform lives. You will be involved with the early stages of these regulatory submissions. The Sr. Regulatory Affairs professional is responsible for supporting all aspects of the Regulatory Affairs Department as well as some Quality Assurance activities.
Reporting to the VP of Regulatory Affairs, this position, the incumbent will use his/her extensive knowledge of Regulatory Affairs and Quality Assurance to provide support and guidance to other departmental staff as well as coordination and preparation of IND related documents, agency correspondence and other regulatory responsibilities.
Coordination and preparation of documents for INDs and related regulatory submissions including amendments, annual reports, new protocol submissions, protocol amendments, safety reports, agency correspondence, etc.
Maintaining and archiving Regulatory and Quality System documents within the document management system
Preparation, review, approval and maintenance of documents related to GMP, GCP and GLP activities
Manages the exchange of regulatory and quality documents between external partners and vendors involved in publishing regulatory documents
Manages the rolling, monthly, quarterly and annual data collection & generating quality reports for Quality Management System
Maintains internal clinical Trial Master Files
Manages other Regulatory and Quality activities as needed
Bachelor’s degree in a relevant scientific discipline
4-6 years hands-on regulatory affairs experience
IND preparation experience preferably with therapeutic biologics
IT capability and competence with document management systems (such as Master Control) and eCTD publishing systems
Basic understanding of the drug development process and Quality Management Systems
Willingness to learn new activities and keep current on ever changing Regulatory Agency regulations and policies relating to drug development
Work independently and trouble shoot independently
Strong organizational skills
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Please visit our careers site at http://www.immunomix.com/careers/. Send your cover letter and credentials as described on the Careers page along with the Job Code: 2018 RA002 in the subject line.
Equal Opportunity Employer
Internal Number: 2018 RA002
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the LAMP-based nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health. On the heels of two landmark deals in 2015, including an exclusive worldwide license with Astellas Pharma Inc. to explore the use of LAMP-Vax™ for use in the prevention and treatment of allergic diseases which resulted in over $315M in licensing revenue that year, the company has now focused on the application of LAMP technology in oncology.
The mission of Immunomic Therapeutics is to pioneer vaccines that transform lives.
Immunomic Therapeutic’s vision is that by 2025, it will have regulatory approved products in pollen allergy, food allergy, cancer and animal health.